- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07268547
Wrist Reduction Intervention: Supracondylar Technique for Radial Nerve Block vs. Hematoma Block (WRIST Block Study)
December 11, 2025 updated by: Aaron Grossberg, Sarasota Memorial Health Care System
The purpose of this study is to compare different types of local anesthesia-a supracondylar radial nerve block, a hematoma block, or a combination of the two-for reducing pain in people with a broken wrist (distal radius fracture).
This is being done to find out which method provides better pain relief after the injury and during treatment in the emergency room.
Study Overview
Status
Enrolling by invitation
Conditions
Intervention / Treatment
Detailed Description
This study is testing different ways to provide pain relief before reducing a broken wrist.
Participants will receive one of three techniques: (1) a nerve block where a doctor injects lidocaine near the radial nerve under ultrasound guidance; (2) a hematoma block where a doctor injects lidocaine into the area where the bone broke; or (3) both the nerve block and the hematoma block.
Patients will be asked how much pain they feel before the numbing, after the numbing, and after the wrist is reduced.
Study Type
Interventional
Enrollment (Estimated)
105
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Florida
-
Sarasota, Florida, United States, 34239
- Sarasota Memorial Health Care System
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 18 years of age or older
- Patients admitted to the ECC with a distal radius fracture requiring closed reduction
- Patient must be willing and able to provide informed consent to the study
Exclusion Criteria:
- Under 18 years of age
- Pregnant
- Prisoner
- Allergy to lidocaine
- Patients unable to provide informed consent and/or perform study-related activities
- Patients undergoing procedural sedation
- Patients may be excluded at the discretion of the investigator based on their clinical judgment, if the participant no longer meets criteria, and/or if the health or safety of the patient may be impacted by taking part in the study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Supracondylar radial nerve blocks
Lidocaine injection given near the radial never under ultrasound guidance
|
Supracondylar radial nerve blocks given at the radial nerve not as the same location of the fracture site, prior to fracture reduction.
|
|
Experimental: Hematoma blocks
Injecting analgesia into the hematoma that forms surrounding the wrist fracture
|
Injection of analgesia into the hematoma that forms surrounding the wrist fracture.
|
|
Experimental: Combination of supracondylar radial nerve block and hematoma block
Supracondylar radial nerve block given first followed by hematoma block
|
Supracondylar radial nerve block given first, followed by hematoma block, before fracture reduction.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain levels comparison
Time Frame: Pain will be measured at (1) baseline, (2) after administering the assigned pain block(s), and after the (3) fracture reduction.
|
Comparing pain levels among patients who are undergoing a wrist fracture reduction. Measured on a scale of 0-10, 0= no pain to 10= worst pain. Pain will be measured at (1) baseline, (2) after administering the assigned pain block (s), and after the (3) fracture reduction. |
Pain will be measured at (1) baseline, (2) after administering the assigned pain block(s), and after the (3) fracture reduction.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Amount of opioid medication needed to control pain.
Time Frame: Opioid medication prescribing will be assessed at baseline, time of admission to the emergency room, until the patient is discharged and they are no longer active in the study.
|
The amount of opioid prescribed, if any, will be collected and recorded for comparison during patient's time in emergency room.
|
Opioid medication prescribing will be assessed at baseline, time of admission to the emergency room, until the patient is discharged and they are no longer active in the study.
|
|
Number of patients requiring conscious sedation.
Time Frame: Patients will be monitored for need of conscious sedation from baseline, time of enrollment in the study, until discharge from the emergency room, when they are no longer active in the study.
|
The need for conscious sedation among patients undergoing wrist fracture reduction in emergency care center will be recorded and monitored for comparison between groups.
|
Patients will be monitored for need of conscious sedation from baseline, time of enrollment in the study, until discharge from the emergency room, when they are no longer active in the study.
|
|
Adverse Events Monitoring
Time Frame: From baseline, time the patient is admitted and enrolled into the study, until the patient is discharged and no longer active in the study.
|
Adverse events associated with any of the blocks that are administered to patients undergoing a wrist fracture reduction in the emergency care center will be identified, monitored, and recorded for reporting.
|
From baseline, time the patient is admitted and enrolled into the study, until the patient is discharged and no longer active in the study.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Aaron Grossberg, DO, Sarasota Memorial Health Care System
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Tseng PT, Leu TH, Chen YW, Chen YP. Hematoma block or procedural sedation and analgesia, which is the most effective method of anesthesia in reduction of displaced distal radius fracture? J Orthop Surg Res. 2018 Mar 27;13(1):62. doi: 10.1186/s13018-018-0772-7.
- Siebelt M, Hartholt KA, van Winden DFM, Boot F, Papathanasiou D, Verdouw BC, de Vries MR, Mathijssen NM, Kraan GA. Ultrasound-Guided Nerve Blocks as Analgesia for Nonoperative Management of Distal Radius Fractures-Two Consecutive Randomized Controlled Trials. J Orthop Trauma. 2019 Apr;33(4):e124-e130. doi: 10.1097/BOT.0000000000001388.
- Oakley B, Busby C, Kulkarni S, Arnold SJ, Kulkarni SS, Ollivere BJ. Manipulation of distal radius fractures: a comparison of Bier's block vs haematoma block. Ann R Coll Surg Engl. 2023 May;105(5):434-440. doi: 10.1308/rcsann.2022.0116. Epub 2022 Oct 14.
- Maia GAS, Cunha JC, Feijo CQ, Leal DM, Moreira JJ, Herrero CFPDS. Radial Nerve Supracondylar Block Versus Fracture Hematoma Block. Comparison of Their Efficacy in Cases of Fractures of the Distal Third of the Radius. Rev Bras Ortop (Sao Paulo). 2023 Aug 30;58(4):e557-e562. doi: 10.1055/s-0043-1768623. eCollection 2023 Aug.
- Handoll HH, Madhok R, Dodds C. Anaesthesia for treating distal radial fracture in adults. Cochrane Database Syst Rev. 2002;2002(3):CD003320. doi: 10.1002/14651858.CD003320.
- Haley CB, Beauchesne AR, Fox JC, Nelson AM. Block Time: A Multispecialty Systematic Review of Efficacy and Safety of Ultrasound-guided Upper Extremity Nerve Blocks. West J Emerg Med. 2023 Jun 30;24(4):774-785. doi: 10.5811/westjem.56058.
- Gottlieb M, Cosby K. Ultrasound-guided hematoma block for distal radial and ulnar fractures. J Emerg Med. 2015 Mar;48(3):310-2. doi: 10.1016/j.jemermed.2014.09.063. Epub 2014 Dec 9.
- Martinez-Arboleda JJ, Moreno M, Diaz-Solorzano JP, Mejia-Grueso A. Ultrasound-guided supracondylar radial nerve block for closed reduction of a distal radius fracture in the emergency department: Case report. Trauma Case Rep. 2024 Sep 25;54:101116. doi: 10.1016/j.tcr.2024.101116. eCollection 2024 Dec.
- Che Daud AZ, Mohd Nayan NA, Ahmad A, Alrashdi M, Kadar M, Mohd Poot EF. Distal radius fracture rehabilitation: A bibliometric and scoping review. J Hand Ther. 2025 Jul 3:S0894-1130(25)00089-4. doi: 10.1016/j.jht.2025.05.016. Online ahead of print.
- Abbasi S, Garjani N, Mahshidfar B, Farsi D, Mofidi M, Hafezimoghadam P, Rezai M, Javan A. Comparative Study of Radial and Median Nerve Blocks with Hematoma Block under Ultrasound Guide in Distal Radius Fracture Reduction: A Randomized Clinical Trial. Med J Islam Repub Iran. 2023 Oct 23;37:113. doi: 10.47176/mjiri.37.113. eCollection 2023.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 9, 2025
Primary Completion (Estimated)
December 1, 2027
Study Completion (Estimated)
December 1, 2027
Study Registration Dates
First Submitted
November 18, 2025
First Submitted That Met QC Criteria
November 25, 2025
First Posted (Estimated)
December 5, 2025
Study Record Updates
Last Update Posted (Actual)
December 15, 2025
Last Update Submitted That Met QC Criteria
December 11, 2025
Last Verified
December 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 25-MEDI-58
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
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